Manager, Commercial Packaging and Serialization

Key Responsibilities

• Lead, coach, and develop the commercial packaging and serialization team, driving accountability and high performance
• Establish daily/weekly priorities to ensure execution of commercial packaging schedules and shipment timelines
• Provide hands-on operational leadership, including issue escalation, troubleshooting, and decision-making
• Build team capability in GMP/GDP execution, documentation practices, and serialization operations
• Oversee execution of Replimune’s commercial packaging activities, ensuring alignment with production plans and inventory targets
• Ensure packaging operations are performed in accordance with approved batch records, SOPs, and quality requirements
• Maintain continuous inspection readiness across packaging and serialization operations
• Support investigation and resolution of serialization-related deviations, including data discrepancies and EPCIS exceptions
• Shipment to 3PL Support operational activities required to prepare and transfer finished drug product from packaging through shipment to the 3PL
• Ensure all batch records, serialization data, and shipping documentation are complete and accurate prior to transfer
• Collaborate closely with Supply Chain Planning, Warehouse, Quality, Manufacturing, IT, and external vendors as required

Packaging Operations

• Monitor packaging performance (e.g., throughput, right-first-time, deviations) and drive continuous improvement

Serialization Operations

• Manage execution of serialization processes on packaging lines using Antares serialization equipment, including commissioning, aggregation, and reconciliation
• Ensure accurate and timely transfer of serialization data to enterprise systems and external stakeholders through TraceLink
• Monitor serialization performance and proactively resolve issues impacting line operations or data integrity

Shipment to 3PL

• Ensure all batch records, serialization data, and shipping documentation are complete and accurate prior to transfer
• Collaborate with Warehouse and Supply Chain teams to ensure on-time shipment execution

GDP, Compliance & Documentation

• Ensure strict adherence to GDP and GMP requirements across packaging and shipment processes
• Oversee execution and review of batch records, serialization documentation, and SOPs
• Maintain documentation accuracy, completeness, and audit readiness
• Partner with Quality to manage deviations, CAPAs, change controls, and inspections

Packaging Line & Systems Oversight

• Provide operational oversight of packaging line equipment and serialization systems, including Antares interfaces and integration points
• Work cross-functionally with IT to ensure effective utilization of TraceLink and Oracle ERP for transaction visibility and data accuracy
• Support issue resolution across system interfaces (Antares → TraceLink → Oracle)
• Partner with Engineering and Validation to ensure systems remain qualified

Process Ownership & Continuous Improvement

• Own packaging and serialization-related processes, including SOPs and standard work
• Identify and implement improvements to enhance efficiency, reduce deviations, and improve data integrity
• Drive disciplined execution, visual management, and operational excellence within team

Other Responsibilities

• Collaborate closely with Supply Chain Planning, Warehouse, Quality, Manufacturing, IT, and external vendors as required
• Support product launches, artwork changes, and lifecycle management activities
• Ensure packaging and serialization requirements are fully integrated into supply chain execution plans

Qualifications

• Bachelor's degree in Supply Chain, Operations Management, Life Sciences or related field required; advanced degree preferred
• 5+ years of experience in pharmaceutical or biotech manufacturing, packaging, or supply chain operations
• Direct experience with commercial packaging and serialization operations
• Hands-on experience with Antares (or equivalent packaging line serialization systems) and TraceLink (or equivalent serialization platforms)
• Working knowledge of Oracle ERP within a regulated supply chain environment
• Strong experience working in GMP and GDP-regulated environments
• Proven experience with batch record execution/review and SOP management
• Demonstrated people leadership experience in frontline operations
• Strong problem-solving capability with the ability to troubleshoot across equipment, systems, and processes
• Excellent attention to detail and commitment to compliance and documentation accuracy
• Experience supporting product launches in a commercial-stage organization